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Table 2 Participant timeline

From: Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs

 

Baseline (clinic)

6 weeks (clinic)

12 weeks (clinic)

26 weeks (clinic)

52 weeks (remote)

Baseline and other covariates

 Pre-screening form/log (before baseline visit)

X

-

-

-

-

 Eligibility form

X

-

-

-

-

 Surgery details form

X

-

-

-

-

 Informed consent form

X

-

-

-

-

 Contact details

X

-

-

-

-

 Demographics

X

-

-

-

-

 Employment (including sick pay provision)

X

X

X

X

X

 Vehicle use

X

-

-

-

-

 Randomisation (at baseline)

X

-

-

-

-

Primary outcome

 Patient-Rated Wrist and Hand Evaluation (PRWHE)

X

X

X

X

X

Patient-reported measures

 Patient Evaluation Measure (PEM)

X

X

X

X

X

 Work productivity and activity impairment (WPAI)

X

X

X

X

X

 EuroQoL EQ-5D-5L

X

X

X

X

X

 Litigation/compensation

-

-

-

-

X

 Global rating of change (GRoC)

-

X

X

X

X

 Preferences for splint attributes

X

X

-

-

-

Clinical outcomes

 Range of movement

X

X

X

X

-

 Grip strength

-

-

X

X

-

 Splint adherence from heat sensor

-

X

-

-

-

 Complications and AE/SAEs

X

X

X

X

X